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Sponsors and Collaborators: |
Peter MacCallum Cancer Centre, Australia The Leukemia and Lymphoma Society |
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Information provided by: | Peter MacCallum Cancer Centre, Australia |
ClinicalTrials.gov Identifier: | NCT00400556 |
Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma Cutaneous Lymphoma |
Drug: ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Haematopoietic Stem Cell Mobilization Using G-CSF With ATRA in Patients With Cutaneous Lymphoma and Multiple Myeloma |
Estimated Enrollment: | 6 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2005 |
HSPC mobilization is normally achieved using cytokines such as G-CSF, or occasionally GM-CSF, often in combination with myelosuppressive chemotherapy.
Studies in the mouse model have shown that retinoids (vitamin A derivatives) can be combined with G-CSF, and that this combination synergizes to enhance HSPC mobilization over that seen with G-CSF alone.
This trial aims to assess the safety and mobilization efficacy of combining mobilizing doses of G-CSF with a standard dose of ATRA, using a treatment regimen derived from the earlier murine studies.
In this phase I pilot study, six patients with multiple myeloma or cutaneous lymphoma will be treated with ATRA plus G-CSF, and safety and toxicity data collected for the two week study drug period plus a further two weeks' follow-up. The primary endpoint is safety and toxicity, the secondary endpoint is an observation of the mobilization efficacy as demonstrated by CD34+ cell counts over the study period. Patients will not undergo stem cell collection during this study, as this is purely an observational study. Participating patients will not be those who would normally be scheduled for stem cell collection and transplantation in the near future, but rather patients with stable disease who are not candidates for imminent transplantation, or who have collected adequate HSPC on previous mobilization attempts and are currently being observed.
Cutaneous lymphoma and multiple myeloma are chosen as suitable disease states for this study as there is in vitro evidence of a possible disease benefit of retinoids in these disorders. If disease response is noted during the study or follow up period, ongoing ATRA will be offered at the discretion of the treating physician.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Victoria | |
Peter MacCallum Cancer Center | |
East Melbourne, Victoria, Australia, 3002 |
Principal Investigator: | Kirsten E Herbert, MBBS | Peter MacCallum Cancer Center |
Principal Investigator: | Miles Prince, MBBS | Peter MacCallum Cancer Center |
Study ID Numbers: | 04/24 |
Study First Received: | November 15, 2006 |
Last Updated: | November 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00400556 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
mobilization ATRA G-CSF filgrastim |
retinoids stem cell mobilization hematopoietic stem and progenitor cells |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |